ClinicalTrials.gov
ClinicalTrials.gov Menu

Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00315081
Recruitment Status : Unknown
Verified November 2005 by University Hospital, Bonn.
Recruitment status was:  Not yet recruiting
First Posted : April 17, 2006
Last Update Posted : April 17, 2006
Sponsor:
Information provided by:
University Hospital, Bonn

Brief Summary:
Antipsychotic drugs can cause a clinically relevant hyperprolactinemia due to blocking the dopamine receptors in the pituitary.Schizophrenic patients suffering from a neuroleptic-induced hyperprolactinemia will be examined endocrinologically. Adverse drug effects and diagnoses will be confirmed by measuring hormones.

Condition or disease Intervention/treatment Phase
Schizophrenia Hyperprolactinemia Drug: Bromocriptin Phase 3

Detailed Description:

Antipsychotic drugs can cause a clinically relevant hyperprolactinemia due to blocking the dopamine receptors in the pituitary.Depending on its concentration hyperprolactinemia causes a median hypogonadism with estrogen insufficiency in women and testosterone insufficiency in men by inhibiting the pulsatile GnRH-secretion.The hyperprolactinemia-induced symptoms have been successfully medicated for years with dopamine agonists like bromocriptine.

In patients with psychiatric diseases hyperprolactinemia is usually not treated with dopamine agonist fearing a reexacerbation of the underline psychiatric disease. In a few studies and casuistically the treatment of neuroleptic-induced hyperprolactinemia with bromocriptine has been shown to be effective without causing reexacerbation of psychotic symptoms.

Schizophrenic patients suffering from a neuroleptic-induced hyperprolactinemia (in extremis galactorrhoea and amenorrhoea. in women, loss of libido and erectile dysfunction in men) will be examined endocrinologically. Adverse drug effects and diagnoses will be confirmed by measuring hormones (prolactin, LH, FSH, testosterone, estradiol). In case of a clear symptomatic, neuroleptic-induced hyperprolactinemia patients will be medicated with bromocriptin. Therapeutical success will be determined endocrinologically in week 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 together with a psychiatric examination (PANSS, HAM-D, Simpson-Angus Scale (SAS)). Safety of therapy will be ensured by the close meshed psychiatric examinations.


Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapy With Bromocriptine in Patients With Symptomatic Risperidone-Induced Hyperprolactinemia
Study Start Date : May 2006
Study Completion Date : May 2008





Primary Outcome Measures :
  1. Prolactin
  2. LH
  3. FSH
  4. Testosterone
  5. Estradiol

Secondary Outcome Measures :
  1. PANSS
  2. HAM-D
  3. Simpson Angus Scale (SAS)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female and male schizophrenic patients.
  • Antipsychotic treatment with risperidone.
  • Diagnosis of a clinically relevant hyperprolactinemia.
  • No indication of disturbance of the somato-, cortico or thyreotropic hypophysis-axis (IGF-1, cortisol, ACTH, TSH, FT3, FT4)

Exclusion Criteria:

  • Severe somatic disease, especially coronary disease.
  • Acute psychotic exacerbation.
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315081


Contacts
Contact: Kai-Uwe Kuehn, MD 0049-(0)228-287-5681 kai-uwe.kuehn@ukb.uni-bonn.de

Locations
Germany
University of Bonn, Department of Psychiatry Not yet recruiting
Bonn, Northrhine-Westfalia, Germany, 53105
Contact: Kai-Uwe Kuehn, MD    0049-(0)2228-287-5681    kai-uwe.kuehn@ukb.uni-bonn.de   
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Principal Investigator: Wolfgang Maier, MD University of Bonn, Department of Psychiatry

Publications:
ClinicalTrials.gov Identifier: NCT00315081     History of Changes
Other Study ID Numbers: 150-05
First Posted: April 17, 2006    Key Record Dates
Last Update Posted: April 17, 2006
Last Verified: November 2005

Keywords provided by University Hospital, Bonn:
Schizophrenia
Hyperprolactinemia
Risperidone
Bromocriptin

Additional relevant MeSH terms:
Schizophrenia
Hyperprolactinemia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Risperidone
Bromocriptine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Dopamine Agonists